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目的了解B群脑膜炎球菌外膜蛋白(Group B Meningococcal Outer Membrane Protein,MenB-OMP)偶联A+C群脑膜炎球菌结合疫苗(Meningococcus Group A and Group C Conjugate Vaccine,MCVA+C)的免疫原性。方法按2:1比例随机双盲对照试验设计原则,观察3~5月龄、6~23月龄、2~6岁、7~24岁四个年龄组,检测免疫前、后A、B、C群血清杀菌抗体(Serum Bactericidal Antibody,SBA)。结果观察疫苗对不同年龄组免疫前、后A、B、C群SBA同时≥4倍增长率为97.65%~100%,SBA同时≥1:128的占88.89%~96.47%,几何平均滴度为1:194~1:420,与对照组相比差异有统计学意义。结论MenB-OMP偶联MCVA+C有良好的免疫原性。
Objective To understand the immunogenicity of Meningococcus Group A and Group C Conjugate Vaccine (MCVA + C) group B Meningococcal Outer Membrane Protein (MenB-OMP) Sex. Methods According to the principle of 2: 1 ratio randomized double-blind controlled trial design, four age groups of 3 ~ 5 months old, 6 ~ 23 months old, 2 ~ 6 years old and 7 ~ 24 years old were observed. Serum Bactericidal Antibody (SBA). Results The growth rate of SBA in groups A, B and C before and after immunization was 97.65% ~ 100% at different age groups and 88.89% ~ 96.47% at SBA ≥1: 128. The geometric mean titers were 1: 194 ~ 1: 420, compared with the control group, the difference was statistically significant. Conclusion MenB-OMP coupled with MCVA + C has good immunogenicity.